Study of Nivolumab for Non-Small Cell Lung Cancer (Stage III) Following Neoadjuvant Chemotherapy Plus Nivolumab and Definitive Concurrent Chemoradiation Therapy

Conditions

• Stage III Non-small-cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Neoadjuvant therapy — OTHER
  The neoadjuvant therapy before radiotherapy comprised of Docetaxel 60 mg/m2 for 1 hour + Cisplatin 75 mg/m2+Nivolumab 360 mg, once every 3 weeks (Q3W), for a total of 2 cycles.
• Chemotherapy concurrent with radiotherapy — OTHER
  Docetaxel 25 mg/m2 for 1 hour +Cisplatin 25 mg/m2, once a week (QW)
• Radiotherapy — RADIATION
  Hypofractionated radiation technique was used to deliver a definitive radiation dose
• Nivolumab — DRUG
  Nivolumab consolidation (360 mg) via iv infusion once every 3 weeks (Q3W)±3 days after the neoadjuvant therapy and concurrent chemo-radiotherapy. Administration of nivolumab will commence on Day 1 following randomisation to Nivolumab after confirmation of eligibility and will continue on a Q3W schedule for a maximum duration of 12 months.
• Observation — OTHER
  Observation after the neoadjuvant therapy and concurrent chemo-radiotherapy.

Study Details

The phase II, randomised Study is to explore the efficacy and safety of nivolumab as consolidation therapy in patients with locally advanced, unresectable non-small cell lung cancer (stage III) who have not progressed following neoadjuvant chemotherapy plus nivolumab and definitive concurrent chemoradiation therapy

Key Dates

Start date

Nov 28, 2019

Status verified

Apr 2024

Primary completion

Jan 31, 2025

Completion

Jan 31, 2025

Study Design

Enrollment

264 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Nivolumab Consolidation
  Patients in experimental group will receive Nivolumab consolidation (360 mg) via iv infusion Q3W±3 days after the neoadjuvant therapy and concurrent chemo-radiotherapy.
• Active Comparator: Observation
  Patients in this group will receive observation after the neoadjuvant therapy and concurrent chemo-radiotherapy.

Primary Outcome Measure

Progression-free Survival [ Time Frame: 2 years ]